BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONICBEAT 5 MM, 35 CM, INLINE GRIP

    MDR report key: 11521014 · Received March 18, 2021

    Report

    Report Number
    8010047-2021-03940
    Event Type
    Malfunction
    Date Received
    March 18, 2021
    Date of Event
    February 6, 2021
    Report Date
    March 19, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    LFL
    PMA / PMN Number
    K111202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE PROBE WAS BROKEN OFF AT 15.5 MM FROM THE DISTAL END. THERE WAS SCRATCH AROUND THE BROKEN POINT. THE FRACTURE SURFACE OF THE PROBE SHOWED THAT CRACK DEVELOPED. THE MANUFACTURING RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. BASED ON THE PAST SIMILAR CASES, IT WAS KNOWN THAT THE PROBE WAS CRACKED WHEN THE USER ACTIVATED OUTPUT CONTACTING WITH METAL OR SOMETHING HARD OBJECT SUCH AS METAL CLIPS, STAPLER, OR OTHER INSTRUMENTS, BESIDES THE PROBE WAS BROKEN OFF WHEN THE PROBE WAS SUBJECTED TO A LOAD. THE ABOVE DEVICE HANDLING HAS WARNED IN THE INSTRUCTION MANUAL.

    Description of Event or Problem · 1

    WE RECEIVED THE FOLLOWING REPORT FROM THE HEALTH PROFESSIONAL. *DURING AN UNSPECIFIED PROCEDURE, THE SUBJECT DEVICE WAS USED. THE PROBE OF THE SUBJECT DEVICE WAS BROKEN OFF. THERE WAS NO REPORT THAT THE FRAGMENT FELL INSIDE THE PATIENT. DETAILS OF AN ERROR WERE UNKNOWN. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408318 SONICBEAT 5 MM, 35 CM, INLINE GRIP INSTRUMENT LFL OLYMPUS MEDICAL SYSTEMS CORP. SB-0535IC 0XK

    Patients

    Seq Age Sex Outcome Treatment
    1